Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07286188
Phase
PHASE4
Status
Recruiting

Conditions

  • Fibroids, Uterine
  • Fluid Deficit
  • Hysteroscopy / Methods

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Misoprostol Tabets — DRUG
    800 mcg of misoprostol will be administered per rectum to intervention group prior to their scheduled hysteroscopic myomectomy.
  • Placebo — DRUG
    4 tablets of Zeebo (Microcsrystalline cellulose) placebo tablets will be placed per rectum to prior to undergoing a hysteroscopic myomectomy, for patients assigned to the placebo arm.

Study Details

The goal of this double blinded randomized control trial is to evaluate the impact of misoprostol on fluid deficit during hysteroscopic myomectomies. The main questions it aims to answer are: Is there is difference in fluid deficit in patients who receive misoprostol vs placebo pre operatively for hysteroscopic myomectomies? Participants will be randomized to received 800 mcg of either rectal misoprostol prior to their hysteroscopic myomectomy or 4 tablets of placebo (ZEEBO) prior to their hysteroscopic myomectomy.

Key Dates

Start date
Dec 16, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Misoprostol (treatment aem)
    Patients will received 800 mcg of misoprostol per rectum prior to procedure.
  • Placebo Comparator: Zeebo (Placebo arm)
    Patient will receive 4 tablets of placebo (ZEEBO) per rectum prior to procedure.

Primary Outcome Measure

Fluid Deficit [ Time Frame: Immediately at the conclusion of the procedure. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NorthwesternChicagoIllinois60611
Hannah Pope, MD
3126946773
Juan Avitia, MPH

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